Senior Scientist, Quality Control

About the role

The Scientist 3 - QC is responsible for performing testing of raw materials, in-process and finished pharmaceutical dosage forms, products on stability, cleaning verification samples following written procedures and applicable SOPs. They also calculate and report results on applicable specification documents, participate in method transfer activities, and provide feedback on systems and analytical procedures to promote continuous improvement and enhance compliance posture.

Responsibilities

• Perform physical and chemical analysis of raw materials, in-process, and finished pharmaceutical products, including products on stability, according to written methods, material specification, and company policies as identified in standard operating procedures (SOPs).
• Comply with cGMPs, SOPs, and STPs to avoid out-of-specification situations.
• Assure compliance with state and federal regulations.
• Participate in any project work as and when assigned.
• Perform process validation and cleaning validation/verification testing on various drugs.
• Assist other scientists with analytical, instrument, and software-related problems as required.
• Use sonic sifter, laser diffraction, Karl Fischer, UV-Vis spectrophotometer, Infra-red spectrophotometer, HPLC with UV detection as well as with conductivity detection, TLC, pH meter, and dissolution.
• Calibrate HPLC, Dissolution apparatus equipped with auto-sampler and/or in-line UV, pH meters, analytical balances, and Karl-Fischer titrator.
• Document steps followed during analysis execution, calculate and report results.
• Actively participate in investigation of laboratory results.
• Review laboratory analysis data for completeness, specification compliance, and compliance with company's written policies.
• Report any abnormal findings to the Supervisor.
• As assigned, perform in-depth review of analytical records/reports to assure that calculations and other data are technically correct and compliant to relevant specifications.

Qualifications

• Education: Bachelors Degree (BA/BS) in Chemistry or related science discipline - Required
• Experience: 5 years or more with Bachelors Degree (BA/BS) - Testing of chemicals/pharmaceutical products
• Experience: 3 years or more with Masters Degree (MS/MA) - Testing of chemicals/pharmaceutical products
• Specialized Knowledge: Must possess in-depth knowledge of analytical chemistry techniques, such as spectrophotometric, dissolution and drug release, chromatographic techniques (standalone or hyphenated) and measuring physical parameters (viscosity, particle size or droplet size by laser diffraction, melting point by DSC, water content by TGA, identification by XRPD, and other techniques).
• Knowledge: Must be able to follow compendial (USP/EP/BP/JP) procedures for analysis.
• Knowledge: Must understand and apply cGMP requirements applicable to quality control laboratory.
• Skills: Must have ability to apply advanced technical skills to troubleshoot and resolve complex analytical and instrument-related problems effectively and in a timely manner and report actions to the laboratory management in a timely manner.
• Skills: Must be able to identify trends in analytical data.

Benefits

Amneal offers a comprehensive, flexible, and competitive benefits program for eligible positions that includes above-market, diverse, and robust health and insurance benefits to meet the varied needs of our employees, as well as a significant 401(k) matching contribution to help our employees save for retirement. We also promote employee well-being with programs that help you enjoy your career alongside life's many other commitments and opportunities.

Pay

The base salary for this position ranges from $85,000 to $123,000 per year. Amneal ranges reflect the Company's good faith estimate of base salary that Amneal reasonably believes that it will pay for said position at the time of the posting. Individual compensation will ultimately be determined based on a variety of relevant factors, including but not limited to, qualifications, geographic location, and other relevant skills.

Schedule

N/A